Active substances
Fish oil + Medium chain triglycerides + Olive oil + Soybean oil
- US FDA 1
- Health Canada 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SMOFLIPID 20% | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML); 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML); 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML); 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | emulsion · intravenous | FRESENIUS KABI USA | Prescription | 13 Jul 2016 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| SMOFLIPID 20% | 02396963 | 3 % / W/V; 6 % / W/V; 6 % / W/V; 5 % / W/V | EMULSION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
Components
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.